3-A Sanitary and Hygienic

Darcoid works with Rubber Fab which has a large inventory of O-Rings for Cherry Burrell®, Evergreen®, International Paper®, Pure Pak®, Liqui-Box®, Nimco®, Gram®, Sweetheart®, Portion Pak®, Anderson® and other sanitary fillers. Standard materials available include Buna, EPDM, FKM and Silicone.The gasket materials considered are Tuf-Steel® (PTFE/Stainless Steel),Tuf-Flex®, PTFE, Silicone (Platinum), FKM Fluoroelastomer, EPDM and Buna-N.

Most decisions driving seal type selection are based on chemistry, temperature, exposure limits, USP, FDA  qualifications, and curing methods.

In determining correct sanitary gasket materials, the following criteria are used:

•  U.S. Pharmacopeia Class VI Certification

•  Cytotoxicity Criteria 

•  CFR Title 21 Section 177.1550 

•  CFR Title 21 Section 177.2600 

•  Traceability: Lot and Batch Certification: Lot and Batch 

•  ASME-BPE Standards 

•  USDA Standards 

•  3-A  Sanitary Standards 

•  Current Good Manufacturing Practices (CGMP) 

•  Manufacturer data and specifications 

•  Consultation with various pharmaceutical users

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